None listed
Conditions
Interventions
FOLLOWING THE PRE-SCREEING/WASHOUT PERIOD AND 2 WEEK PLACEBO RUN IN, ELIGIBLE PATIENTS WILL BE RANDOMIZED IN A 1:1 RATIO AT VISIT 3 TO ONE OF THE TWO TREATMENT GROUPS. AFTER 4 WEEKS OF TREATMENT AT VI
Sponsors
MERCK & CO.INC.,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: ALL VISITS GENERAL 1. PATIENT IS MALE OR FEMALE ≥ 18 AND ≤ 85 YEARS OF AGE ON DAY OF SIGNING INFORMED CONSENT. 2. PATIENT UNDERSTANDS THE STUDY´S PROCEDURES; ALTERNATIVE TREATMENTS AVAILABLE, RISKS INVOLVED WITH THE STUDY, AND VOLUNTARILY AGREES TO PARTICIPATE BY GIVING WRITTEN INFORMED CONSENT. 3. A FEMALE PATIENT MUST MEET ONE OF THE FOLLOWING: a. OF REPRODUCTIVE POTENTIAL AND AGREES TO REMAIN ABSTINENT OR USE (OR HAVE THEIR PARTNER USE) 2 ACCEPTABLE METHODS OF BIRTH CONTROL FOR THE STUDY DURATION. AN ACCEPTABLE METHOD OF BIRTH CONTROL IS DEFINED AS: • INTRAUTERINE DEVICE (IUD) • DIAPHRAGM WITH SPERMICIDE • CONDOM • VASECTOMY • NON-CYCLIC HORMONAL CONTRACEPTION-MUST HAVE BEEN ON A STABLE DOSE FOR GREATER THAN 6 WEEKS PRIOR TO VISIT 1 AND AGREE TO REMAIN ON THE SAME REGIMEN FOR THE DURATION OF THE STUDY • CONTRACEPTIVE SPONGE (WITH SPERMICIDE) IS ACCEPTABLE AS A SINGLE METHOD OF BIRTH CONTROL BUT REQUIRES ONE OF THE FOLLOWING AS A SECOND METHOD: INTRAUTERINE DEVICE (IUD), DIAPHRAGM, CONDOM OR VASECTOMY VASECTOMY: A SUCCESSFUL IS DEFINED AS: (1) MICROSCOPIC DOCUMENTATION OF AZOOSPERMIA, OR (2) A VASECTOMY MORE THAN 2 YEARS AGO WITH NO RESULTANT PREGNANCY DESPITE SEXUAL ACTIVITY WITHOUT BIRTH CONTROL POSTVASECTOMY.
Exclusion criteria
Exclusion criteria: ALL VISITS GENERAL 1. PATIENT IS PREGNANT OR BREAST-FEEDING, OR EXPECTING TO CONCEIVE DURING THE STUDY INCLUDING THE 14-DAY POST STUDY FOLLOW UP. 2. PATIENT HAS A HISTORY OF MALIGNANCY ≤ 5 YEARS PRIOR TO SIGNING INFORMED CONSENT, EXCEPT FOR ADEQUATELY TREATED BASAL CELL OR SQUAMOUS CELL SKIN CANCER OR IN SITU CERVICAL CANCER. 3. FEMALE PATIENT IS EXPECTING TO DONATE EGGS DURING THE STUDY, INCLUDING THE 14-DAY FOLLOW-UP OR A MALE PATIENT IS EXPECTING TO DONATE SPERM DURING THE STUDY, INCLUDING THE 14-DAY FOLLOW-UP. 4. PATIENT IS UNLIKELY TO ADHERE TO THE STUDY PROCEDURES, KEEP APPOINTMENTS, OR IS PLANNING TO RELOCATE DURING THE STUDY, OR HAS A HISTORY OR CURRENT EVIDENCE OF ANY CONDITION, THERAPY OR LAB ABNORMALITY THAT MIGHT CONFOUND THE RESULTS OF THE STUDY, INTERFERE WITH THE PATIENT´S PARTICIPATION FOR THE FULL DURATION OF THE STUDY, OR IF THERE IS ANY REASON IT IS NOT IN THE BEST INTEREST OF THE PATIENT TO PARTICIPATE. 5. PATIENT CONSUMES MORE THAN 3 ALCOHOLIC DRINKS ON ANY GIVEN DAY OR MORE THAN 14 DRINKS PER WEEK. SEE SECTION 3.2.3 FOR DEFINITION OF ALCOHOLIC DRINKS. 6. PATIENT IS CURRENTLY PARTICIPATING IN OR HAS PARTICIPATED IN A PRIOR STUDY WITH: • AN INVESTIGATIONAL COMPOUND (OTHER THAN LIPID-MODIFYING) WITHIN 30 DAYS FROM THE POST-STUDY FOLLOW-UP PERIOD, PRIOR TO RANDOMIZATION. • A LIPID-MODIFYING COMPOUND (INVESTIGATIONAL OR MARKETED), OTHER THAN FIBRATE WITHIN 6 WEEKS FROM THE POST-STUDY FOLLOW-UP PERIOD, PRIOR TO RANDOMIZATION.
Countries
Mexico, United States
Contacts
Public ContactAnibal Enrique Salas
COVANCE PERU SERVICES S.A.
Outcome results
None listed